MFDS reviews GMP standards for sterile preparations abroad

Analyzes international regulatory trends...to support the establishment of a stable system for the domestic pharmaceutical industry

Explores research initiatives related to sterility testing for large-volume parenteral solutions, development of Contamination Control Strategies (CCS), and application of PUPSIT (Pre-use Post-sterilization Integrity Testing).

With the Ministry of Food and Drug Safety planning to enforce revised GMP standards for sterile drug products reflecting PIC/S international standards in December, it plans to identify research tasks on items that require international harmonization by analyzing the regulatory status of reference countries.

 

Ahead of its re-entry into PIC/S in 2023, the MFDS announced the “Regulations on Drug Manufacturing and Quality Control (MFDS Notice)” that contained a risk assessment-based systematic contamination management strategy and operational plan to enhance the quality assurance level of sterile drug products.

 

Instead of implementing PIC/S-level strengthened GMP for sterile preparations in December as planned, the MFDS has decided to establish guidelines for large-volume parenteral solutions, contamination control strategies (CCS), and PUPSIT (Pre-use Post-sterilization Integrity Testing), referring to the results of the “Study on the Implementation of Sterile GMP Regulatory Harmonization” currently being conducted by the Manufacturing Quality Innovation Committee of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association.

 

Additionally, the MFDS recently announced a bid for the “Study on Implementation Strategies for Regulatory Harmonization of Manufacturing and Quality Control Based on Global GMP Trend,” aiming to establish implementation strategies for manufacturing and quality control based on an analysis of international regulatory trends, including those of advanced pharmaceutical countries and PIC/S regulations, to support the stable adoption of regulatory systems within the domestic pharmaceutical industry.

 

The objective of the study is to establish a strategic foundation for regulatory harmonization in the pharmaceutical GMP field and expand domestic pharmaceutical exports by conducting a gap analysis based on research into international GMP regulatory trends.

 

To this end, the regulatory status and implementation cases of advanced pharmaceutical countries and major PIC/S member countries (such as the United States, Europe, and Japan) will be studied, and gap analysis will be conducted between domestic GMP regulations and PIC/S GMP regulations to identify research tasks requiring international regulatory harmonization.

 

In particular, the gap analysis will include the period before and after the revision of domestic GMP standards for sterile drug products, and future research tasks will include consideration of aseptic testing for large-volume parenteral solutions, the establishment of a CCS, and the application of PUPSIT.

 

In addition, the formation of a pool of domestic and international experts in related fields, and consulting with relevant experts when necessary or holding seminars or presentations for the domestic pharmaceutical industry with invited external GMP experts as needed will also be studied.

 

Based on the results of this study, the Ministry of Food and Drug Safety (MFDS) plans to develop draft guidelines for research topics requiring international regulatory harmonization.